Tapping devices, systems and methods for use in bone tissue

ABSTRACT

A soft tapping device for preparing a bone hole that includes a substantially cylindrical insert that is sized to enter into a compressed woven retention device. The substantially cylindrical insert has protrusions that are adaptable to expand portions of a compressed woven retention device inside the bone hole. The substantially cylindrical insert is also configured to exit from the compressed woven retention device without changing the expanded portions of the compressed woven retention device.

RELATED APPLICATIONS

This application claims priority to U.S. provisional application No.62/201,273, filed Aug. 5, 2015, and U.S. provisional application No.62/287,756, filed Jan. 27, 2016.

TECHNICAL FIELD

The present invention relates to devices, systems and methods for use infixing fasteners to bone tissue.

BACKGROUND

In orthopedic surgery it is common to secure a bone screw to a patient'sbone. Bone fracture repair is surgery to fix a broken bone using plates,nails, screws, or pins. It is common in the treatment of fractures toattach a plate to the bone utilizing bone screws. The resultingconstruct prevents motion of the fractured bone so that the bone canheal. Alternatively, one or more screws may be inserted across the breakto hold it in place.

In the treatment of spinal disorders, pedicle screws are inserted intothe patient's vertebrae to serve as anchor points that can then beconnected with a rod. This construct prevents motion of the vertebralsegments that are to be fused.

In the treatment of detached tendons, screw-like tissue anchors areinserted into the patient's bone to serve as an anchor for thereattachment of the tendon.

One complication with the use of bone screws is the loss of fixation orgrip between the bone screw and the patient's bone. Another complicationwith the use of bone screws is the stripping of the hole in the bonewhen the bone screw is inserted. This results in the loss of purchaseand holding strength of the bone screw.

The presence of osteoporotic bone can increase the likelihood ofcomplications by reducing the purchase or grip of the bone screw to thepatient's bone, resulting in a loss of holding strength and loosening ofthe bone screw or pullout of the bone screw.

Current solutions to secure bone screws have not adequately addressedscrew failure and the underlying causes of screw failure. Also, currentsolutions have not adequately addressed screw failure related tobi-cortical intramedullary anchorage.

One solution contemplates utilizing a woven retention device above thebone surface to engage with a bone screw. However, this solution mayrequire precise placement of the woven retention device to preventinterference with screw engagement.

BRIEF SUMMARY OF THE INVENTION

There is a need for devices, systems and methods that enhance thesurface of a bone hole to provide enhanced fixation of a bone anchor tothe bone. Additionally, there is a need for devices, systems and methodsfor repairing the surface of the bone hole following damage to the bonehole as in the case of stripping of the hole in the bone when a bonescrew is over-tightened. Also, there is a need for devices, systems andmethods for providing an enhanced bone hole surface for the reattachmentof tendons in, for example anterior/posterior cruciate ligament repairprocedures, rotator cuff repair procedures, etc. There is a need for adevice that enhances the surface of a bone hole to enhance fixation of abone anchor to bone and permits bone ingrowth into its structure. Thereis a need for a single device that enhances the surface of a bone holeto enhance fixation of a bone anchor to bone and accommodates variationsin the diameter and depth of the bone hole. Further, there is a need forsuch devices that have enhanced biocompatibility to aid in tissue andbone healing, regeneration, and growth.

According to an embodiment of the present invention, the level of thematerial of a woven retention device above the bone surface can be veryimportant. If the level of the woven retention device is too deep thenthe screw may not find the lumen and/or may push the woven retentiondevice with the screw as the screw proceeds into the lumen. On the otherhand, if the woven retention device is too proud, there may bedifficulty engaging bone, there may be fiber disruption, or there may bedebris formation. Another challenge lies in the general difficulty inengaging bone with the interposition of the woven retention device. Forexample, a diameter mismatch may occur between the pilot hole and thescrew (2.5 mm vs 3.5 mm).

A woven retention device can be reduced in diameter and inserted into apilot hole that spans a near cortex and a far cortex. In between thenear cortex and the far cortex, there is no intramedullary bone in oneembodiment. A self-tapping screw can then be inserted into the alreadyinserted woven retention device. The screw upon entering the wovenretention device can dilate a portion of the woven retention device backto its natural diameter. As the screw continues to proceed to the end ofthe woven retention device, the woven retention device continues todilate to fit. As the screw approaches a far or near cortex or innercortex bone, an area of a woven retention device that becomessusceptible to breakage or damage as the screw and the bone can pinch orput pressure on a portion of the woven retention device.

To ameliorate this, a soft tapping device is contemplated in accordancewith the principles of the invention. The soft tapping device is shownand described herein in various embodiments. The soft tapping devicecan, any of, contact, engage, compact, compress, expand and/or dilatebone, with respect to the bone inside a bone hole alone, and/or, incombination with a fixation device, for example, a woven retentiondevice.

In one aspect of the invention, a soft tapping device comprises asubstantially cylindrical insert sized to enter into a compressed wovenretention device, the substantially cylindrical insert havingprotrusions that are adaptable to expand portions of a compressed wovenretention device inside a pilot hole, the substantially cylindricalinsert being configured to exit from the compressed woven retentiondevice without changing the expanded portions of the compressed wovenretention device. In another aspect of the invention the protrusions area non-cutting thread having a gradually increasing pitch in a proximaldirection along the substantially cylindrical insert. In another aspectof the invention, the protrusions are expanding balloon members thatexpand in an outward direction when the substantially cylindrical insertis compressed in a longitudinal direction. In another aspect of theinvention, the substantially cylindrical insert includes slots whichform tensioned slats, wherein the protrusions are the tensioned slats;and the protrusions expand in an outward direction when thesubstantially cylindrical insert is compressed in a longitudinaldirection. In another aspect of the invention, the expanded portions ofthe compressed portions of the compressed woven retention device allowfor a self-tapping screw to insert into the woven retention devicewithout damaging the woven retention device. In another aspect of theinvention, the soft tapping device further comprises a shaft with aproximal portion and a distal portion, wherein the distal portion isconfigured with a non-cutting thread and a rounded end. In anotheraspect of the invention, the soft tapping device further comprises ashaft with a proximal portion and a distal portion, wherein distalportion is configured with a first thread portion and the proximalportion is configured with a second thread portion with a coarser pitchthan first thread portion of the distal portion, and wherein the secondthread portion is rounder than the first thread portion.

In another aspect of the invention, a soft tapping device comprises asubstantially cylindrical insert configured and sized to expand portionsof a substantially cylindrical hole, the substantially cylindricalinsert being configured to exit from the hole without changing theexpanded portions of the hole. In another aspect of the invention, thesoft tapping device further comprises a shaft with a proximal portionand a distal portion, wherein the distal portion is configured with anon-cutting thread. In another aspect of the invention, the non-cuttingthread has a radially spiral configuration. In another aspect of theinvention, the non-cutting thread has a base and a radially outward-mostpeak in between the proximal portion and a distal end of the distalportion. In another aspect of the invention, the hole is a bone hole. Inanother aspect of the invention, the hole is a woven sleeve configuredto be disposed in a bone hole. In another aspect of the invention, thehole is a combination of a bone hole and a woven sleeve in the bonehole. In another aspect of the invention, the soft tapping devicefurther comprises a spring-loaded deburring tool on the shaft.

In another aspect of the invention, a method of creating a mantle in abone comprises inserting a compressed woven retention device into apilot hole of a bone; inserting a soft tapping device into thecompressed woven retention device, wherein the soft tapping device hasridges that, when inserted into the compressed woven retention device,expand the woven retention device with lead in edges; and inserting aself-tapping screw into the expanded woven retention device. In anotheraspect of the invention, the method further comprises the step of:expanding the inserted woven retention device with a leading edge of aridge on the soft tapping device. In another aspect of the invention,the method further comprises the step of: removing the soft tappingdevice without cutting the expanded woven retention device. In anotheraspect of the invention, the method further comprises the step of:inserting one of a screw and a self-tapping screw into the pilot holeafter the soft tapping device is removed. In another aspect of theinvention, the method further comprises the step of: inputting a slurryinto the pilot hole before inserting the screw.

In another aspect of the invention, a method of creating a mantle forfixation in bone comprises providing a soft tapping device configured tocompress material in a bone hole; utilizing a soft tapping device tocompress the material in the bone hole; and inserting a woven retentiondevice. In another aspect of the invention, the soft tapping device isconfigured to provide a surface of the bone hole with soft edges. Inanother aspect of the invention, the method further comprises insertinga compressed woven retention device into the bone hole, the compressedwoven retention device being adapted to expand to fill the soft edges ofthe bone hole. In another aspect of the invention, the method furthercomprises inserting a screw into the inserted woven retention device. Inanother aspect of the invention, inserting the screw comprises insertinga self-tapping screw into the compressed woven retention device. Inanother aspect of the invention, the method further comprises adding anadditive to at least one of the expanded woven retention device and bonehole, wherein the additive is a different material than the wovenretention device. In another aspect of the invention, the additive is aslurry that is configured to form a composite material mantle thatinterfaces with the self-tapping screw. In another aspect of theinvention, the slurry is a calcium phosphate cement. In another aspectof the invention, the material is in one of: 1) situ bone; 2) bonematerial and a woven retention device; and 3) bone material, a wovenretention device and a slurry.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of a woven retention device in relation to abone hole.

FIG. 1B shows a side view of a woven retention device placed in a bonehole.

FIG. 2A shows a side view of one embodiment of the invention placed in along bone, illustrating features that mate with the promixal and distalcortex of the bone.

FIG. 2B shows a top view of one embodiment of the invention.

FIG. 2C shows a side view of a bone screw placed within a wovenretention device placed in a bone hole.

FIG. 3A shows a side view of an embodiment of the invention.

FIG. 3B shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 3C shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 3D shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 3E shows a close-up side view of a central portion of an embodimentof the invention.

FIG. 4A shows a side view of another embodiment of the invention.

FIG. 4B shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 4C shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 5A shows a side view of another embodiment of the invention.

FIG. 5B shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 5C shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 5D shows a cross-section view of an embodiment of the invention.

FIG. 5E shows a close-up side view of a distal end of an embodiment ofthe invention.

FIG. 6 shows a side view of another embodiment of the invention.

FIG. 7 shows a side view of another embodiment of the invention.

FIG. 8A shows a side view of another embodiment of the invention.

FIG. 8B shows a side view of another embodiment of the invention.

FIG. 9A shows a side view of another embodiment of the invention.

FIG. 9B shows a side view of another embodiment of the invention.

FIG. 9C shows a cross-section of another embodiment of the invention.

FIG. 10A shows a side view of another embodiment of the invention.

FIG. 10B shows a side view of another embodiment of the invention.

FIG. 10C shows a side view of another embodiment of the invention.

FIG. 10D shows a side view of another embodiment of the invention.

FIG. 10E shows a side view of another embodiment of the invention.

FIG. 10F shows a side view of another embodiment of the invention.

FIG. 10G shows a side view of another embodiment of the invention.

FIG. 10H shows a side view of another embodiment of the invention.

FIG. 10I shows a side view of another embodiment of the invention.

FIG. 11A shows a schematic of the threading in an embodiment of theinvention.

FIG. 11B shows a schematic of the threading in an embodiment of theinvention.

FIG. 12 shows a side view of a bone hole in an embodiment of theinvention.

FIG. 13A shows a schematic of the threading in an embodiment of theinvention.

FIG. 13B shows a cross-section of the shaft in an embodiment of theinvention.

FIG. 14A shows a side view of another embodiment of the invention.

FIG. 14B shows a close-up view of the bone hole in an embodiment of theinvention.

FIG. 15A shows a perspective view of the relaxed state of anotherembodiment of the invention.

FIG. 15B shows a perspective view of the activated state of anembodiment of the invention.

FIG. 16A shows a perspective view of the relaxed state of anotherembodiment of the invention.

FIG. 16B shows a perspective view of the activated state of anembodiment of the invention.

FIG. 16C shows a close-up perspective view of the activated state of anembodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

As shown in FIG. 1A, a woven retention device 1 may be placed in a bonehole 3 located within a bone 2. The bone hole 3 may be substantiallycylindrical. The woven retention device 1 may initially be in acompressed state, as shown in FIG. 1A. The woven retention device 1 maydistribute pressure from the bone screw to multiple points of contact onthe exterior surface of the woven retention device 1. The wovenretention device 1 may be the woven retention device disclosed in U.S.Pat. No. 8,992,537, which is incorporated by reference herein.

As shown in FIG. 1B, a soft tapping device 100 having soft edges can bedesigned to run inside the woven retention device 1 after the compressedwoven retention device has been placed in the pilot hole. The softtapping device 100 is a substantially cylindrical insert and can expandthe woven retention device 1, as shown in FIG. 1B, and then exit thebone hole 3 so that a self-tapping screw can then enter the expandedwoven retention device 1 without damage to the woven retention device 1because of the soft edges. This allows for the woven retention device 1to be properly placed within the bone hole 3 in a desired location, withdesired dilation. In an embodiment, the soft tapping device 100 may alsobe designed to be inserted in the bone hole before a woven retentiondevice has been placed in the hole.

As shown in FIG. 2A, the soft tapping device 100 may be inserted intothe bone hole 3, such that it passes through the proximal cortex 2 a ofthe bone, and is inserted into the distal cortex 2 b of the bone. Asshown in FIG. 2B, the soft tapping device 100 includes a head 110, whichincludes a tool attachment surface 111 that allows for a driving tool todrive the soft tapping device 100 into the bone 2. In an embodiment, thetool attachment surface 111 may be a hex head, for example a Torx hexhead. The proximal end of the shaft 101 near the head 110 is notthreaded to avoid engagement with the bone and thus reduce friction andback-out resistance. The soft tapping device 100 includes a shaftportion 101, distal end 102, and a distal tip portion 103. The softtapping device 100 further includes a thread 120 on an outer surface ofthe soft tapping device 100. The thread 120 may have a radially spiralconfiguration.

As shown in FIG. 2C, after the soft tapping device 100 is removed fromthe bone 2 and/or the woven retention device 1, the woven retentiondevice 1 is properly placed within the proximal cortex 2 a and distalcortex 2 b of the bone 2, and dilated to a particular diameter toaccommodate a particular bone screw 4. It is understood that the softtapping device 100 is shaped to dilate and place the woven retentiondevice 1 without damaging the woven retention device 1.

The thread 120 may be of the type that compresses the bone 2, wovenretention device 1, and/or composition in a bone hole 3 as describedherein. For example, the thread 120 can make up the soft edges of thesoft tapping device, as detailed above. In an embodiment, the softtapping device 200 does not cut into the bone 2, woven retention device1 and/or composition. The term “cut” is intended to be used broadly toinclude the separation of at least a portion of a physical object, intotwo or more portions, through the application of an acutely directedforce. The soft tapping device 100 does not have a cutting thread like atraditional screw or tap. The soft tapping device 100 can have anon-cutting thread provided on the soft tapping device. The applicationof a tap (as defined broadly as a helical threaded feature) permits alocalized dilating of the bone to reduce the radial force needed tocompact the bone. As shown in FIG. 2A, the soft tapping device can havea helical thread at the distal portion of the device. The term“non-cutting thread” is intended to be used broadly to include threadsthat are of the type that preferably do not cut the bone and/or wovendevice, and that can be non-cutting at the crest of the thread, forexample, they can be rounded at the crest of the thread, so as to notcut what it comes into contact with, for example, so as to not cut thebone and/or woven retention device. Non-cutting threads can includethreads with no cutting flutes or features such as a longitudinalscallop that is intended to engage bone on its sharp edge to bite intobone. As shown in FIG. 13A, non-cutting thread can also include threadsthat have blunt, truncated or soft edges at the crest of the thread,whereas cutting threads 126 have triangular or sharp edges at the crestof the thread. These non-cutting threads can include rounded threads 121and square threads 122 that do not have a sharp peak that can cut intobone. The threads of the soft tapping device can also mimic the threadgeometry of the screw that is intended to be inserted into the wovenretention device, so the screw follows the thread path created by thesoft tapping device. In this way, the bone is dilated in a pattern thatis in the shape of the screw pitch. FIG. 13B shows a cross-section ofthe soft tapping device 100, where threads 120 extend from the coresurface of the shaft 101 and have soft edges at the radiallyoutward-most peak or crest 124 of the thread 120.

As shown in FIGS. 3A-C, in a first embodiment, a soft tapping device 200can be configured, as discussed above, with a shaft portion 101, distalend 102, distal tip portion 103, and thread 120. The edges of the softtapping device 200 can be in the shape of a center bulging ridged insertwhere the soft tapping device gradually increases in diameter. In thisembodiment, the distal tip 103 includes thread 120 wherein the threadpitch is tight enough to grab the surface, but the thread is somewhatrounded to avoid aggressive cutting. In an embodiment, a soft tappingdevice 200 with a 2.5 mm shaft diameter may include thread 120 that mayhave a 1 mm pitch at the distal tip, which increases to an 8 mm pitch atthe proximal end of the distal tip. The thread may have a maximum outerdiameter of 3.5 mm, and the distal tip may have a 12° taper angle.Further, the thread 120 on the shaft 101 may be coarser with a greaterpitch, where the thread pitch may also increase in the proximaldirection, and a thread geometry that is even rounder than at the distaltip 103. For example, as shown in FIG. 3D, the thread 120 may be roundedbeginning with a radius of 0.2 mm, and height of 0.5 mm at the distaltip 103 and have a 60° thread angle. Contrastingly, as shown in FIG. 3E,the thread 120 at the shaft 101 may be more rounded with a radius of0.32 mm, and a height of 0.55 mm, and have a 29° thread angle. Thethread 120 may have a base 125 and a radially outward-most peak or crest124. In this embodiment, the distal end 102 may be rounded with a nearcortex chamfer leading edge 104 that meets the distal tip 103. Thisshape of the distal end 102 allows for the soft tapping device 200 topress against the bone 2 without cutting it before the first threadengages.

The soft edges of the soft tapping device 100 can expand the wovenretention device and provide a “lead in” at the diameter mismatch areas.Thus, the soft edges of the soft tapping device 100, i.e. the thread120, can act as a lead in edge that expands the woven retention device.Alternatively, or additionally, soft edges can expand, dilate and/orcompress the bone material in the bone hole and provide a “lead in” atthe diameter mismatch areas. As shown in FIG. 2A, the distal cortex 2 bis compounded by the fact that the woven retention device 1 uponreaching the distal cortex 2 b is now constrained.

As shown in FIGS. 4A-C, in an embodiment, the distal tip 103 of a softtapping device 201 may be tapered directly into the distal end 102, andhave a greater taper than the soft tapping device 200 of FIG. 3A. In anembodiment, the thread 120 on the soft tapping device 201 may have thesame shape and size on the distal tip 103 and the shaft 101. In anembodiment, the thread 120 on the shaft 101 may have an increasing pitchin the proximal direction. The thread 120 may have a finer pitch atdistal tip 103 than the soft tapping device 200 of FIG. 3A. Thispromotes engagement with the bone 2. In an embodiment, the distal end102 may have a narrower end that also includes a chamfer 104 between thedistal end 102 and the distal tip 103. This rounded shape of the distalend 102 allows for the soft tapping device 201 to slightly pierce bone 2and allow a smaller diameter thread to engage with the bone beforetapering to a larger diameter.

While in some embodiments the soft tapping devices disclosed can be usedto prepare the woven retention device for a self-tapping screw to enterthe woven retention device, in another embodiment the soft tappingdevice can be a self-tapping screw. In an embodiment, the soft tappingdevice 202 may be configured where the distal end 102 and distal tip 103is not tapered but configured with threads like a cutting tap, where thethreads transition to a coarser pitch for the soft tap featuremid-shaft, and there are no threads at the proximal end. As shown inFIG. 5A-D, the distal end 102 and distal tip 103 of the soft tappingdevice 202 may have a thread 120 that is different than the proximal endand shaft 101. The distal tip 103 has threads that may be sharper (e.g.triangle thread versus square or rounded, as discussed with respect toFIG. 13A) and a smaller pitch to engage the proximal surface of theproximal cortex on starting and the proximal end of the distal cortexsurface. This allows the screw tip to self-center and the wovenretention device to displace laterally and allows the screw to engage.The proximal end has even softer thread geometry, such as roundedthreads and a coarser pitch as discussed above with respect to FIGS.3A-E. Thus, the soft edges can provide enough expansion to allow aself-tapping screw to be used. As shown in detail in FIGS. 5D-E, in anembodiment the distal tip 103 of soft tapping device 202 may havecortical thread 120 that is scalloped or saw-toothed, to further engageand cut into the bone 2. This allows for the soft tap thread 120 toengage the bone 2 quickly. In an embodiment, as shown in FIG. 5D, thethread 120 has an outer diameter of 2.45 mm at the distal tip 103, andan outer diameter of 2.6 mm at the shaft 101. The distal tip 103 may be2.8 mm long, and the distal end 102 may have a radius of 0.85 mm. Asshown in FIG. 5E, the cortical thread 120 may have a height of 0.375 mm,a 35° angle at the distal face, a 3° angle at the proximal face, and aradius of 0.05 mm at the surface.

As shown in FIG. 6, in an embodiment the distal tip 103 of the softtapping device 203 may have more rounded thread 120.

As shown in FIG. 7, in an embodiment, the soft tapping device 204 mayinclude a distal tip 103 with a similar pitch and taper as soft tappingdevice 201 as shown in FIG. 4A. In an embodiment, the shaft 101 of thesoft tapping device 204 is smooth, with no threading. This preventsengagement of the soft tapping device 200 with both cortices 2 a, 2 b atthe same time.

Additionally, as shown in FIGS. 8A-B, the soft tap may have longitudinalcleanout grooves 105 along part or all of the length that runs along alongitudinal axis of the soft tapping device 205, 206. This allows forthe removal of debris as the soft tapping device 205, 206 moves throughthe bone so that any bone fragments or various other debris can exit thebone lumen. For example, FIG. 8A shows the embodiment of FIG. 7, butfurther including longitudinal cleanout grooves 105 along the distal tip103 of the soft tapping device 205. Similarly, FIG. 8B shows theembodiment of FIG. 4A, but further including longitudinal cleanoutgrooves 105 along the distal tip 103 of the soft tapping device 206.

As shown in FIG. 9A, an embodiment of the soft tapping device 207 mayhave thread 120 of consistent shape and size, with an invariable veryfine pitch. As shown in FIG. 9B, an embodiment of the soft tappingdevice 208 may have a rounded thread 120 of consistent shape and size,with a variable pitch. As shown in FIG. 9C, the soft tapping device 100may also have a shaft 101 that tapers throughout the cylindrical body,before reaching the distal end 102. This may allow for more gentleintroduction into the woven retention device 1, while providing arelatively small distal end 102.

As shown in FIGS. 10A-H, embodiments of the soft tapping devices 100 mayhave an increased ratio of thread height to shaft 101 core, in order toincrease engagement with bone 2. In an embodiment, a shaft 101 corediameter may be 1.5 mm. In these embodiments, the soft tapping devices100 may include a tip as shown in FIG. 5C, using a cortical thread 120profile. In these embodiments, the taper on the tip may be very low, toallow gradual engagement of these sharper cortical threads. In theseembodiments, the shaft portion 101 may have thread 120 with increasedpitch with soft rounded threads, to allow for a more aggressiveengagement. In an embodiment, a cortical profile thread on the tip mayhave a pitch of 1 mm and a tip thread outer diameter of either 2.45 or2.5 mm. It is understood that these various embodiments may be selectedby a user to fit an appropriate bone hole or pilot hole.

More specifically, in FIG. 10A, in an embodiment, soft tapping device209 includes a thread pitch at the shaft portion 101 of 2 mm, with amaximum outer diameter of 2.6 mm. The soft tapping device 209 may have a38.5 mm working length, measured from the base of the head 110 to thefirst thread 120. In FIG. 10B, soft tapping device 210 includes a threadpitch at the shaft portion 101 of 2 mm, with a maximum outer diameter of3.2 mm. The soft tapping device 210 may have a 54.4 mm working length,measured from the base of the head 110 to the first thread 120. In FIG.10C, soft tapping device 211 includes a thread pitch at the shaftportion 101 of 2 mm, with a maximum outer diameter of 3.5 mm. The softtapping device 211 may have a 54.4 mm working length, measured from thebase of the head 110 to the first thread 120. In FIG. 10D, soft tappingdevice 212 includes a thread pitch at the shaft portion 101 of 4 mm,with a maximum outer diameter of 2.9 mm. The soft tapping device 212 mayhave a 58.4 mm working length, measured from the base of the head 110 tothe first thread 120. In FIG. 10E, soft tapping device 213 includes athread pitch at the shaft portion 101 of 4 mm, with a maximum outerdiameter of 3.2 mm. The soft tapping device 213 may have a 58.4 mmworking length, measured from the base of the head 110 to the firstthread 120. In FIG. 10F, soft tapping device 214 includes a thread pitchat the shaft portion 101 of 4 mm, with a maximum outer diameter of 3.5mm. The soft tapping device 214 may have a 58.4 mm working length,measured from the base of the head 110 to the first thread 120. In FIG.10G, soft tapping device 215 includes a thread pitch at the shaftportion 101 of 6 mm, with a maximum outer diameter of 2.9 mm. The softtapping device 215 may have a 67.4 mm working length, measured from thebase of the head 110 to the first thread 120. In FIG. 10H, soft tappingdevice 216 includes a thread pitch at the shaft portion 101 of 6 mm,with a maximum outer diameter of 3.2 mm. The soft tapping device 216 mayhave a 67.4 mm working length, measured from the base of the head 110 tothe first thread 120. In FIG. 10I, soft tapping device 217 includes athread pitch at the shaft portion 101 of 6 mm, with a maximum outerdiameter of 3.5 mm. The soft tapping device 217 may have a 67.4 mmworking length, measured from the base of the head 110 to the firstthread 120.

As shown in FIGS. 11A-B, in an embodiment the thread 120 may have a path123 along the soft tapping device 100. As shown in FIG. 11A, at thedistal tip 103, the pitch may be 1 mm, where the taper expands from 0.56mm to 2.4 mm. The thread 120 may have 7 revolutions around the distaltip 103, with an overall length of 7 mm. As shown in FIG. 11B, at theshaft, the pitch may be 1 mm, with a consistent shaft diameter of 2.4mm. The thread 120 may have 12 revolutions around the shaft 101, with anoverall length of 36 mm. In addition, or alternatively, the soft tappingdevice 100 can be inserted into a bone or pilot hole 3 to compact,compress, expand and/or dilate the bone or pilot hole 3 before insertionof the woven retention device into the bone hole. This soft tappingdevice 100 can create a bone bed or mantle 5 in the bone material of thebone or pilot hole 3, as shown in FIG. 12, so that when the wovenretention device and/or screw is introduced into the bone or pilot hole3, the bone 2, woven retention device 1 and screw 4 engage reliably.Indeed, a self-tapping screw can be utilized with the woven retentiondevice without damage to the woven retention device.

The soft tapping device 100 can have soft edges that create acomplementary impression in the surface of the bone tissue of the bonehole 3. Thus, the complementary impression can provide recesses to thesoft edges of the soft tapping device 100 that provide ridges. The softtapping device 100 can have threads 120 that are the same or differentfrom a screw that could create a track for screw threads to follow ornot to follow. In this manner, an interface for screws to cut throughfor better fixation can be created.

The soft tapping device 100 can be used to push out and/or compress bonein a radial direction of the bone or pilot hole 3. Additionally, oralternatively, the soft tapping device 100 can be used to push outand/or dilate the woven retention device outward, which when the wovenretention device 1 is inside the bone hole 3 can similarly push outand/or compress bone out in a direction of the bone or pilot hole 3.This pushed-out bone surface with or without the expanded wovenretention device 1 inside the bone hole can be referred to as a layer ormantle, as shown in FIG. 12. The term “mantle” is intended to beinterpreted broadly to encompass the bone material in the bone hole 3that will engage and/or interface with a fastener either directly orindirectly. In one embodiment, the mantle, layer, or composite 5 can becreated solely by arranging and/or configuring the existing bonematerial inside the bone hole 3 utilizing the soft tapping device 100.The process of soft tapping through radially expanding and/orcompressing bone material radially outwardly can be repeated one or moretimes. The bone 2 can be prepared with the bone's own material alonebefore insertion of a woven retention device 1, the bone's own materialand a woven retention device 1 together, e.g., after the woven retentiondevice 1 is inserted in the bone hole 3, and/or with the bone's ownmaterial and a third element, feature or substance that can be added,e.g., added to the bone hole and/or the woven retention device. Thethird item can be a substance as described herein and can be differentfrom the bone tissue and the woven retention device 1.

In an embodiment, a third substance, or an additive different from thewoven retention device, can be added to the bone or pilot hole 3 beforeor after the woven retention device 1 has been inserted into the bone orpilot hole 3. The third substance or additive can facilitate theformation of a mantle 5 of a composite material into which a fastenercan then be introduced. The third substance can be bone material, suchas autograft or allograft, or bone substitute materials, such as bonecement. The third substance or additive can be a slurry. The slurry canbe any of a number of slurries known in the art including calciumphosphate cement slurries. The third substance can be in situ bone, bonematerial and a woven retention device 1, or bone material, a wovenretention device 1, and a slurry. In this manner, an insert, layer ormantle can be created from the inside of the bone or pilot hole 3. Thislayer or mantle 5 can provide for improved screw fixation and/or for usewith various screw types including both self-tapping andnon-self-tapping screws.

A bone hole 3 in accordance with the principles of the invention can beformed or created in various non-limiting ways. For example, the bonehole can be formed in a bone either by creating a pilot hole by suchmeans as drilling, tapping, use of an awl or other instruments, or inthe form of a screw stripping a pilot hole. Thus, a pilot hole as usedherein can refer to a bone hole freshly drilled or stripped by a screwor formed in a bone in other ways. A soft tapping device 100 cancompress and/or expand the pilot hole and provide soft edges to thepilot hole based on the exterior surface of the soft tapping device,before or after a woven retention device has been inserted into thepilot hole. A slurry can be added into the pilot hole either with thewoven retention device or before insertion of the woven retention deviceinto the pilot hole. The slurry may be a different material from thewoven retention device. A fastener, such as a bone screw, can then beinserted to interface with the soft-tap created mantle 5 inside thepilot hole.

The above embodiments envision the woven retention device 1 beinginserted into the bone hole 3 and then the soft tapping device 100 isinserted inside the woven retention device 1 to further dilate the holeas well as embed the woven device into the bone, forming a bone-wovendevice-composite mantel. However, the soft tapping device 100 can beinserted into the bone hole 3 before the woven retention device 1, thuspreparing and conditioning the hole. Then the woven device is inserted.This sequence reduces insertion force for the woven device, as well asensuring the woven device is uniformly radially expanded in the hole.All of the soft tap embodiments disclosed above can be applied in thissequence. In addition, the alternative combination of insertion the softtapping device, then inserting the woven retention device and thenre-inserting the soft tapping device into the woven retention device mayprovide additional benefit, depending on the condition of the bone, thebone hole size and shape, etc.

Preparing the bone hole for the woven retention device as describedabove can be accomplished with other configurations of the soft tappingdevice. The soft tapping device geometry can target a specific locationwithin the bone hole. For example, in FIG. 14A, the soft tapping devicecan have features that condition the proximal end of the distal cortexonly. Shown in the FIG. 14A is a spring-loaded surface 130 that deburrsand/or chamfers the proximal side of the distal cortex bone surfacecreating a lead-in feature. As shown in FIG. 14B, the spring-loadeddeburring tool may create a chamfered hole 6 at the surface of the bone2, which can create a larger area for the woven retention device 1 or abone fastener to enter the bone hole 3. This feature can be incorporatedwith any of the above embodiments of the soft tapping device 100.

Similar to the deburring function described above, in the scenario ofinserting the soft tapping device prior to insertion of the wovenretention device, the soft tapping device can have more aggressivecutting features or an even separate “hard tap” device can be insertedinto the bone hole to core or cut some or all of the bone hole edges toprepare the hole for the woven retention device, as discussed withrespect to FIGS. 5A-B, above. This is counterintuitive to the surgeonwho works to not remove bone assuming that even a small amount of bonewill improve screw retention.

As shown in FIGS. 15A-B and 16A-C, embedding the woven retention deviceand/or compacting the bone hole surface can be accomplished with otherexpandable configurations. For example, a soft tapping device 301, 302may be formed such that the relaxed tap may be inserted into the hole,and activated by compressing the proximal end of the soft tapping device301, 302. Activating the soft tapping device increases its diameter intotal or in a localized way. For example, as shown in FIGS. 15A-B, the“threads” as described above can be protrusions 310 that are expandedradially from the shaft of the soft tapping device, such as aballoon-type device that forms balloon members. FIG. 15A shows a relaxedsoft tapping device 301, which is tensioned or deflated such that theshaft surface is smooth and of a uniform diameter. FIG. 15B shows anactivated soft tapping device 301, where the soft tapping device 301 iseither compressed in a longitudinal direction or inflated, such that theprotrusions 310 expand in an outward direction from the shaft of thesoft tapping device 301. In this case, the expanded feature is notintended to remove bone but to push/compact bone away from the shaftradially.

Alternatively, other mechanical means can be employed to expand thesebone compacting features. For example, there can be singular or multipleexpandable features of FIG. 16A-C that are located at various positionsalong the longitudinal axis, creating radially expanded features alongthe length. For example, FIG. 16A shows a relaxed soft tapping device302, which is tensioned such that the shaft surface is smooth and of auniform diameter. FIG. 16B shows an activated soft tapping device 302,where the soft tapping device 302 is compressed in a longitudinaldirection, such that the protrusions 320 expand in an outward directionfrom the shaft of the soft tapping device 301 to create expandedportions. FIG. 16C shows the activated soft tapping device 302 in moredetail, where the surface of the soft tapping device 301 includes slots321, that form tensioned protrusion slats 322 that can expand in anoutward direction from the shaft of soft tapping device 302 to createexpanded portions. In this case, the expanded feature is not intended toremove bone but to push/compact bone away from the shaft radially. Othermechanical means besides the two-end constrained leaf spring-likemechanism as shown in FIGS. 15A-B and 16A-C can be used to expand aportion or multiple of portions of the device.

The various embodiments and inventions contemplated here are preferablyutilized in with a woven device, for example, a woven retention device.An exemplary woven retention device contemplated for use in accordancewith the principles of the invention are described and shown in, forexample, U.S. Pat. No. 8,956,394, filed Aug. 5, 2014 and U.S. Pat. No.8,992,537, filed Sep. 16, 2014, the contents of which are herebyincorporated by reference herein in their entireties.

The embodiments illustrated and discussed in this specification areintended only to teach those skilled in the art how to make and use theinvention. In describing embodiments of the invention, specificterminology is employed for the sake of clarity. However, the inventionis not intended to be limited to the specific terminology so selected.The above-described embodiments of the invention may be modified orvaried, without departing from the invention, as appreciated by thoseskilled in the art in light of the above teachings. It is therefore tobe understood that, within the scope of the claims and theirequivalents, the invention may be practiced otherwise than asspecifically described.

1. A soft tapping device, comprising: a substantially cylindrical insertsized to enter into a compressed woven retention device, thesubstantially cylindrical insert having protrusions that are adaptableto expand portions of a compressed woven retention device inside a pilothole, the substantially cylindrical insert being configured to exit fromthe compressed woven retention device without changing the expandedportions of the compressed woven retention device.
 2. The soft tappingdevice of claim 1, wherein the protrusions are a non-cutting threadhaving a gradually increasing pitch in a proximal direction along thesubstantially cylindrical insert.
 3. The soft tapping device of claim 1,wherein the protrusions are expanding balloon members that expand in anoutward direction when the substantially cylindrical insert iscompressed in a longitudinal direction.
 4. The soft tapping device ofclaim 1, wherein the substantially cylindrical insert includes slotswhich form tensioned protrusion slats, wherein the protrusions are thetensioned protrusion slats; and the protrusions expand in an outwarddirection when the substantially cylindrical insert is compressed in alongitudinal direction.
 5. The soft tapping device of claim 1, whereinthe expanded portions of the compressed portions of the compressed wovenretention device allow for a self-tapping screw to insert into the wovenretention device without damaging the woven retention device.
 6. Thesoft tapping device of claim 1 further comprising a shaft with aproximal portion and a distal portion, wherein the distal portion isconfigured with a non-cutting thread and a rounded end.
 7. The softtapping device of claim 1 further comprising a shaft with a proximalportion and a distal portion, wherein distal portion is configured witha first thread portion and the proximal portion is configured with asecond thread portion with a coarser pitch than first thread portion ofthe distal portion, and wherein the second thread portion is rounderthan the first thread portion.
 8. A soft tapping device, comprising: asubstantially cylindrical insert configured and sized to expand portionsof a substantially cylindrical hole, the substantially cylindricalinsert being configured to exit from the hole without changing theexpanded portions of the hole.
 9. The soft tapping device of claim 8further comprising a shaft with a proximal portion and a distal portion,wherein the distal portion is configured with a non-cutting thread. 10.The soft tapping device of claim 8, wherein the non-cutting thread has aradially spiral configuration.
 11. The soft tapping device of claim 8,wherein the non-cutting thread has a base and a radially outward-mostpeak in between the proximal portion and a distal end of the distalportion.
 12. The soft tapping device of claim 8, wherein the hole is abone hole.
 13. The soft tapping device of claim 8, wherein the hole is awoven retention device configured to be disposed in a bone hole.
 14. Thesoft tapping device of claim 8, wherein the hole is a combination of abone hole and a woven retention device in the bone hole.
 15. The softtapping device of claim 8, further comprising a spring-loaded deburringtool on the shaft.
 16. A method of creating a mantle in a bone,comprising: inserting a compressed woven retention device into a pilothole of a bone; inserting a soft tapping device into the compressedwoven retention device, wherein the soft tapping device has ridges that,when inserted into the compressed woven retention device, expand thewoven retention device with lead in edges; and inserting a self-tappingscrew into the expanded woven retention device.
 17. The method of claim16, further comprising the step of: expanding the inserted wovenretention device with a leading edge of a ridge on the soft tappingdevice.
 18. The method of claim 17, further comprising the step of:removing the soft tapping device without cutting the expanded wovenretention device.
 19. The method of claim 18, further comprising thestep of: inserting one of a screw and a self-tapping screw into thepilot hole after the soft tapping device is removed.
 20. The method ofclaim 19, further comprising the step of: inputting a slurry into thepilot hole before inserting the screw. 21-28. (canceled)